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Adverse events a .

التفاصيل البيبلوغرافية
العنوان: Adverse events a .
المؤلفون: Bruno Martins Tomazini, Lucas Tramujas, Fernando Azevedo Medrado Junior, Samara Pinheiro do Carmo Gomes, Karina Leal Negrelli, Gabriela Souza Murinize, Renato Hideo Nakagawa Santos, Bruna Martins Pereira Vianna, Bruna Fornazieri Piotto, Thabata Silva Veiga, Bianca Rodrigues do Santos, Ana Clara Peneluppi Horak, Olivia Mora Cavalcante Lemos, Marcela de Almeida Lopes, Beatriz Baptista Olicheski, Diego Lurentt Campones, Luiz Angelo Alencar Peixoto, Aline dos Anjos Chaves Basilio, Otavio Celso Eluf Gebara, Ana Tarina Alvarez Lopes, Humberto Saconato, Nanci Valeis, Tamiris Abait Miranda, Ligia Nasi Laranjeira, Eliana Vieira Santucci, Aaron Foster Carlin, Jeffrey David Esko, Phillip Leo Stephan Marie Gordts, Sotirios Tsimikas, Alexandre Biasi Cavalcanti
سنة النشر: 2024
مصطلحات موضوعية: Biochemistry, Medicine, Microbiology, Cell Biology, Biotechnology, Evolutionary Biology, Cancer, Infectious Diseases, Virology, Chemical Sciences not elsewhere classified, trna synthetase inhibitor, symptomatic (&# 8804, serious adverse events, within 10 days, statistically significant difference, mean decay rate, hospitalized adult patients, receive halofuginone 0, 19 halofuginone treatment, halofuginone 1mg group, decay rate, 10 days, mean difference, hospitalized adults, halofuginone 1mg, halofuginone 0, placebo group, %22">xlink ">, well tolerated, vitro <
الوصف: Background Halofuginone (PJS-539) is an oral prolyl-tRNA synthetase inhibitor that has a potent in vitro activity against SARS-CoV-2 virus. The safety and efficacy of halofuginone in Covid-19 patients has not been studied. Methods We conducted a phase II, randomized, double-blind, placebo-controlled, dose ranging, safety and tolerability trial of halofuginone in symptomatic (≤ 7 days), mostly vaccinated, non-hospitalized adults with mild to moderate Covid-19. Patients were randomized in a 1:1:1 ratio to receive halofuginone 0.5mg, 1mg or placebo orally once daily for 10 days. The primary outcome was the decay rate of the SARS-CoV-2 viral load logarithmic curve within 10 days after randomization. Results From September 25, 2021, to February 3, 2022, 153 patients were randomized. The mean decay rate in SARS-CoV-2 viral load log 10 within 10 days was -3.75 (95% CI, -4.11; -3.19) in the placebo group, -3.83 (95% CI, -4.40; -2.27) in the halofuginone 0.5mg group and -4.13 (95% CI, -4.69; -3.57) in the halofuginone 1mg group, with no statistically significant difference in between placebo vs. halofuginone 0.5mg (mean difference -0.08; 95% CI -0.82 to 0.66, p = 0.96) and between placebo vs. halofuginone 1mg (mean difference -0.38; 95% CI, -1.11; 0.36, p = 0.41). There was no difference on bleeding episodes or serious adverse events at 28 days. Conclusions Among non-hospitalized adults with mild to moderate Covid-19 halofuginone treatment was safe and well tolerated but did not decrease SARS-CoV-2 viral load decay rate within 10 days.
نوع الوثيقة: dataset
اللغة: unknown
Relation: https://figshare.com/articles/dataset/Adverse_events_sup_a_sup_/25277703
DOI: 10.1371/journal.pone.0299197.t003
الاتاحة: https://doi.org/10.1371/journal.pone.0299197.t003
https://figshare.com/articles/dataset/Adverse_events_sup_a_sup_/25277703
Rights: CC BY 4.0
رقم الانضمام: edsbas.24848CDD
قاعدة البيانات: BASE
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